With the continuous development of social economy and innovation of production technology in pharmaceutical industry, people pay more and more attention to the quality and safety of pharmaceutical products in the envi...With the continuous development of social economy and innovation of production technology in pharmaceutical industry, people pay more and more attention to the quality and safety of pharmaceutical products in the environment of GMP certification, namely certification, good manufacturing practice, which belongs to the national monitoring and inspection system for production and business activities and a way for pharmaceutical companies. There are some quality problems in the pharmaceutical production site. This paper analyzes the quality management methods of the production site after the GMP certification of sterile pharmaceutical products, aiming at further improving the quality and safety of sterile pharmaceutical products. Therefore, the purity requirements for the production of sterile pharmaceutical products are very high, and must be strictly controlled in the production process. Especially, with the introduction of the new version of GMP, the purity requirements for sterile pharmaceutical products have been improved. Sterile pharmaceutical production enterprises must strengthen their management. The analysis of the actual situation of the production of sterile drugs meeting the new requirements indicates that the management of the production site should be strengthened after obtaining the GMP certificate for the production of sterile drugs. Therefore, in order to ensure the production quality and avoid the quality decline, the quality management of the production site has great practical value for the analysis of the quality management of the production site of sterile drugs after GMP certification. This paper analyzes the quality management of the production site of sterile drugs after GMP certification for reference.展开更多
文摘With the continuous development of social economy and innovation of production technology in pharmaceutical industry, people pay more and more attention to the quality and safety of pharmaceutical products in the environment of GMP certification, namely certification, good manufacturing practice, which belongs to the national monitoring and inspection system for production and business activities and a way for pharmaceutical companies. There are some quality problems in the pharmaceutical production site. This paper analyzes the quality management methods of the production site after the GMP certification of sterile pharmaceutical products, aiming at further improving the quality and safety of sterile pharmaceutical products. Therefore, the purity requirements for the production of sterile pharmaceutical products are very high, and must be strictly controlled in the production process. Especially, with the introduction of the new version of GMP, the purity requirements for sterile pharmaceutical products have been improved. Sterile pharmaceutical production enterprises must strengthen their management. The analysis of the actual situation of the production of sterile drugs meeting the new requirements indicates that the management of the production site should be strengthened after obtaining the GMP certificate for the production of sterile drugs. Therefore, in order to ensure the production quality and avoid the quality decline, the quality management of the production site has great practical value for the analysis of the quality management of the production site of sterile drugs after GMP certification. This paper analyzes the quality management of the production site of sterile drugs after GMP certification for reference.
